8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMAGEN RESPIRATORY SCREEN
FDA 510(k)
FDA Class 1
·Microbiology
TRIATHLON LOW PROFILE TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
Eclipse with VEMP
FDA 510(k)
FDA Class 2
·Neurology
INTERLOCK¿-35
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·February 14, 2013
MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·January 17, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·July 28, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·February 6, 2017
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020